Selling our safety to the highest bidder: the privatisation of Plasma Resources UK

Lucy Reynolds publishes this original paper on the government's proposed sale of the UK's state-owned blood plasma supplier. In their drive to dismantle the last vestiges of the state, the government appear to be exposing the British public to serious - and sometimes fatal - risks, including HIV and hepatitis.

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Abstract

The open market in
plasma products creates incentives to exploit all sources of plasma,
to operate lax donor selection standards and cut corners on infection
control. This allows patients to be infected with lethal diseases.

Following the
generation of the new fatal disease vCJD through reduced UK
regulation of cattle feed processing which transmitted a brain
disease of sheep to cows from where it proved transmissible to
humans, it was no longer safe to make plasma products from UK donors.
So in 2002 the government purchased a US plasma source to be a
protected supply for UK patients. The government now intends to
privatise this supply, leaving the country to rely wholly on the open
market for supplies.

Competition law was
first used by profit-making blood harvesters to force risky blood on
US hospitals in 1956: competition law narratives are always framed
around “the best interests of patients” but in practice they are
no friends of those patients. HIV and blood-borne hepatitis have
infected the majority of US clotting factor users in older age
cohorts.

Nowadays the stakes
are even higher, with more fatal blood-borne infections in the blood
supply and new diseases emerging every few years.

Meanwhile, a boom in
new and in some cases ill-advised new immune-based treatments is
putting huge stress on world supplies of plasma, given that most
developed countries and many developing countries make plasma buying
illegal. This will result in more and more marginal sources of plasma
supply coming into the plasma products market, jeopardising the
patients to whom they are administered.

By the sale of
Plasma Resources UK, our government commits us to buying all plasma
products for UK patients from market suppliers who almost all have a
track record of avoidable quality problems, in many cases resulting
in deaths or serious chronic illness such as HIV.

This paper sets out
the interlocking epidemiological, behavioural and economic basis of
the plasma trade to show why the UK government should follow the
example of most developed countries and protect patients from the
dangerous products regularly circulating on the open market.

Introduction

Alongside the
wholesale privatisation of the NHS which the government are trying to
force through against the wishes of the country, there is another sly
privatisation of a much smaller national treasure.

While most medicines
are extracted from plants or other animals, or synthesised, some
life-saving medications are extracted from human blood plasma. While
some of these can now be factory-made through genetic engineering
solutions, others cannot, especially the new “magic bullet” mixed
antibody preparation, intravenous immunoglobulin (IVIG).

In 1975, following
problems with exploitative and unsafe collection of plasma, the World
Health Assembly passed a resolution to protect the health of donors
and recipients. It included recommendations that nations try to
become self-sufficient in blood and blood products; and nations enact
legislation to regulate collection, processing, distribution, export
and import of blood and blood products.1
Ensuring compliance with these precautions requires tight control of
the production process from start to finish. This was previously the
case in the UK.

Unlike other
countries, we can no longer make plasma products from a safe domestic
supply because the fatal disease vCJD was created by infection
control failures in the British meat supply following reduced
regulation. The disease agent has entered the general population but
cannot be reliably detected prior to death. Thus in 2002, to minimise
the need to buy plasma products from the open market, the government
purchased a US plasma collector which the country could regulate to
protect patients. The current government have put this company,
Plasma Resources UK, up for privatisation.

The present
government has already commenced to sell off the blood products made
from our protected source of plasma abroad: at the same time as
exporting from it in bulk, they already buy two-thirds of these
medications for the NHS on the open market, exposing patients to the
risk of the kind of disease outbreaks which have repeatedly been
traced to malpractice in the global plasma trade. Over and over again
this has results in thousands of deaths in countries remote from the
plasma source whose governments were unaware the supplies could be
infected until patients started to sicken and die with AIDS, liver
failure or liver cancer, the last two being the consequences of
contracting Hepatitis B or Hepatitis C, both blood-borne infections.

Payment for plasma
is still permitted in China and the US, the two main sources of the
global supply. It is banned in Western Europe (except Germany),
Canada and Australia for ethical reasons and in order to assure the
safest supply possible. If payment is permitted particularly
stringent care must be taken to ensure that people likely to have
transmissible infections are excluded from selling plasma, as they
may give despite knowing they could be infected in the interests of
acquiring money they badly need.

The day after Lord
David Owen MD learnt of the plan to sell PR UK, he wrote to David
Cameron, as follows (15 March 2013):

“I am writing to you personally because I believe only you can
intervene quickly to stop the pending sale by Lazards of Plasma
Resources UK Ltd. The reason I am writing to you to stop this sale in
its tracks is that in 1975, against some resistance from those
guarding the finances of the DHSS budget, I decided as Minister of
Health to invest in self-sufficiency in the UK for blood and blood
products.

I now believe this country is on the point of making exactly the
same mistake again. I cannot stress enough that we simply do not know
everything about the mutation of genes and the spread of as yet
unidentified infections to be anywhere near certain of relying
exclusively on purchasing plasma supplies on world markets. The world
plasma supply line has been in the past contaminated and I fear it
will almost certainly continue to be contaminated.”

That decision was, sadly, over the years allowed to lapse and
insufficient money allocated for self-sufficiency. This meant that
subsequently the Department of Health felt it necessary to make
available financial compensation for people infected by contaminated
blood supplies, namely, but not exclusively, haemophiliacs. Many
other countries were also heavily criticised for not investing in
self-sufficiency.

His concerns are
well founded: this piece aims to explain why to those with no
knowledge of the grubby global industry which produces the latest
high-tech medicine, as now being promoted by the UK government under
the rubric of “medical innovation.”

This article will
provide an overview of the reasons why there is serious concern about
the unnecessary risks involved in selling this company and committing
to buy all plasma products through the global marketplace.

What is plasma and what are plasma products?

Plasma
is the watery fluid in blood, in which the red and white cells move.
It contains many bioactive proteins, some of which can be extracted
and used as medication, such as antibodies and clotting factors.

While
whole plasma is usually a by-product from donated blood, plasma
products are produced through a different process called
plasmapheresis from a different set of donors. Plasma donors are not
permitted to contribute to the blood supply, and cannot give plasma
if they have recently given blood. During plasmapheresis, the blood
cells are returned to the body while the plasma is drained off.

Plasma
contributions from many people are then pooled together and the
different proteins separated by fractionation (by centrifuging) and
purified out. Commercially viable products are separated from the
rest, packaged and sold.

This
process may take place in a state-controlled organisation or a single
company which take care of the whole process, or split between
different companies each of which deals with only part of the
process. For example processors often buy plasma from unconnected
harvesters rather than operating their own collection facilities.

Plasma
products consisting of purified proteins (also referred to as blood
products) are used in the treatment of many conditions. Albumin is
needed for burns, shock and serious injury. The mixed antibody
preparation IVIG is used for immune disorders, neurological
conditions and a fast-expanding range of other conditions. Single
antibody preparations are used for many therapies, including
protecting unborn children from haemolytic disease resulting from
Rhesus incompatibility, and for producing vaccinations. The best
known and longest established are the clotting factors needed to
treat and protect haemophilia patients who lack the genes to make
them.

Because all of these
blood proteins except albumin are present only in very small amounts
in the blood, many contributions from must be pooled together, and
then separated out by fractionation. IVIG products are prepared
from plasma pooled from at least 3000 to 10,000 contributors.2

Which diseases can be transmitted through
plasma products?

There are three
categories of serious infection which can be passed through blood
products.

Known
serious or fatal infections for which we can test, e.g. HBV, HIV,
HCV, West Nile Virus.3
The last three have all been newly characterised since 1980. All of
these have been passed through US-generated plasma sources, and all
but the last by Chinese plasma supplies.

Known
serious or fatal infections for which we cannot currently test
reliably, such as the prion disease variant Creutzfeld-Jakob Disease
(vCJD)

Unknown
serious or fatal infections (for which we obviously cannot yet
develop tests), including emerging animal diseases. It is worth
remembering that HIV showed up in haemophiliacs infected via
clotting factors very soon after its first discovery, before
screening was possible. Now most older haemophiliacs are
HIV-infected due to past exposure to infected blood products. New
blood-borne infections come to light all the time, for example the
parvoviruses.4

(Parvovirus
B19V has recently been identified in more than half of plasma pools
at two of the 24 Chinese plasma products manufacturers.5
This virus is associated with encephalitis, liver inflammation and
anaemia, especially in immunosuppressed people (such as transplant
patients and HIV-infected haemophiliacs) and foetuses, killing some
of the latter before birth. Other research demonstrated that 60% to
100% of plasma pools were contaminated, depending on the manufacturer
(85% overall), all Factor VIII, 20% of IVIG, and 75% of intramuscular
immunoglobulin preparations (IMIG) containing traces of B19V.6
A third reported finding B19V DNA in more than 60% of clotting factor
products and plasma pools.7

Parvovirus
PARV4 was discovered in 2005 in an injecting drug user, and is found
at 2% among Los Angeles blood donors and at 6% among injecting drug
users. In haemophiliacs, the transition from a negative to a positive
antibody test for exposure to PARV4 is sometimes accompanied by acute
liver inflammation and skin rashes. PARV4 has been found inside the
cerebrospinal fluid of encephalitis patients and in stillborn babies.
It is not inactivated by heat, detergent or solvent treatments.8
Given its resistance to sterilisation procedures, its ready
transmission through injecting drug use, and its multiple appearance
in haemophiliacs on treatment, it seems likely to be transmissible
through plasma products, though it is too early for conclusive
evidence demonstrating or disproving this to be available.

Other
newly discovered human blood-borne parvoviruses, the bocaviruses, are
known to be related to dog and cattle viruses;8
these have been detected in 5.5% of Italian blood donors.

We
can expect more and more emergent diseases, as because of expanding
population and degradation of land, people live closer and closer to
both livestock and wildlife. The latter contact has already brought
us blood-borne HIV-1 (from the Central African Congo basin, via
chimpanzees killed as bushmeat), the earlier acquisition of HIV-2
from sooty mangabey monkeys in Western Africa, and SARS (from the
Chinese taste for eating exotic wildlife). Intensive farming of
livestock represents another forcing ground for emergent disease.

Prevention for all
of these infections can be done to varying degrees by donor
screening. That screening depends on knowing what characteristics of
donors are statistically associated with them having each infection:
infection routes vary. So avoiding contamination with HIV and
blood-borne hepatitis (HBV and HCV) and other blood-borne disease is
largely a matter of excluding from the plasma supply those who have
been exposed to possibly-contaminated skin-penetrating procedures
such as tattoos or injections of recreational drugs, or to sex with
members of groups especially likely to be infected. For West Nile
Virus the main risk factor for donor exclusion is residence in an
infected zone. For vCJD it is consumption of UK processed meat
products between the relaxation of safety controls on cattle feed
processing and the re-imposition of those controls some years later.
Receipt of blood transfusions permanently excludes donors from
eligibility to give because they can transmit blood-borne disease.

Despite screening,
antibody-based tests may pass a patient with primary infection from a
very recent risk as negative, allowing the infected donation to enter
the transfusion supply. Thus HIV, HBV, HCV and other diseases can
though false negative tests enter the supply. Quarantine protocols
offer some protection against known diseases by catching false
negatives in the case of plasma donations, but this only assists in
the case of the diseases for which tests are both available and used.
There have been persistent problems with substandard screening tests
used in China, creating another system weakness which can cause
contamination to pass into the plasma products.

Plasma products can
be subjected to viral inactivation techniques, but these cannot
destroy all known pathogens.9

A combination of all
of these techniques, carefully executed and independently regulated
on a no-notice basis, should be used to ensure the safest supply.

Standard national blood policy:
self-sufficiency and the Gift Relationship

In plasma
processing, screening of sellers and of their plasma contribution for
known serious blood-borne disease (usually at least HIV and HBV) is
useful, but we lack tests for many blood-borne infections, especially
emerging diseases. Van Dam et al10
highlight the risks inherent in relying on blood testing alone to
manage risk from blood-borne disease, stressing the need to harvest
only from the least contaminated donor pools.

Thus all safe blood
strategies rely on donor selection strategies which attempt to avoid
collection from people who are more likely to have infections that
can pass to patients. Potential plasma contributors are told about
behaviour and circumstances which could have put them at high risk,
and those affected are asked to withdraw from donating. It is known
that paying donors discourages such withdrawal from the supply, so
the average infection burden of the blood rises when donors are paid.

Furthermore, low
cash payments tend to attract, not people with healthy lifestyles
(for whom a few dollars is no incentive to take a day off work), but
those living in precarious circumstances. It is especially suited to
those with a frequent and urgent need to produce small amounts of
cash. This profile of course fits the situation of an addicted
injecting heroin user, and offers to buy blood or plasma tend to
attract them particularly. If they are bled shortly after
contracting HBV, HCV or HIV, the standard antibody-based tests will
miss these very early infections. Unfortunately it is during very
early infection that viral loads are typically at their highest.
Quarantine protocols can be used to eject such donations, but these
require three-month plasma storage and follow-up of every seller.
They are thus expensive to run; producers omitting them can be
considerably more competitive in the market.

In
a New Zealand study11
of options for increasing blood supply, only 75% of donors said that
they would definitely continue giving if they were paid for their
blood, while 11% said that they would definitely cease donating if
payment were made.

41%
of current donors said that they would definitely discontinue
donating if profits were to be made from their blood; another 11%
said that they might discontinue. The 1993 partial privatisation of
New Zealand health services saw higher than normal rates of donor
drop-outs in that year.

These
findings suggest that safe and unsafe donor bases are to some degree
mutually exclusive, so that paying for blood can deter safer donors
from contributing to the blood supply. A UK study of the responses
of active donors, lapsed donors and non-donors to the question:

“If
I were paid enough I would be less/equally/more likely to donate
blood”,

found that pay would
incentivise 16.4% to give, while deterring 14.7%12.
Comparing answers to that question with the following one:

“If
you needed blood, would you be content if the donor had been paid:
yes/no”,

exposed significant
statistical associations between being willing to accept blood from
paid donors and being encouraged to give blood by payment, and
conversely between being unwilling to accept purchased blood and
being deterred from giving by payment. Thus pay for blood may expand
the blood supply at the cost of shifting its composition to include
more of those least aware of the possible health risks posed by
blood-borne disease and fewer of the most health-conscious people.

These studies
confirm the 1972 conclusions of Richard Titmuss13,
who compared the paid American and the unpaid British blood donor
systems finding that the unpaid system increases blood quality and
reduces shortages. He linked this with the altruistic motivation of
the unpaid donors, who have less reason not to follow guidelines to
avoid donating if at risk of blood-borne disease.

A modelling study
using evolutionary game theory also suggests that the existence of
paid donation tends to destroy the social norm of donation as
altruistic, discouraging unpaid donation. It confirms Titmuss’
assertion that once incentives have removed the idea of altruistic
donation, withdrawing them makes matters worse in the short-term, as
paid donors are lost but insufficient voluntary donors replace them.14

The multiplication of blood-borne infection
risk by plasma pooling

The plasma harvested
from many people is pooled to make extracting minority proteins
economically viable, with processing most profitable when the pools
are huge. Although contaminated units are rare in most populations,
risks to blood product recipients may be significant because the
pooling of contributions from thousands of donors15
before fractionation distributes the pathogen content of a single
unit across multiple recipients of the many different plasma products
made from that process batch. If equipment is not properly cleaned,
it could contaminate subsequent batches as well.

To explain the
multiplication of infection risks caused by plasma pooling we can use
a more familiar analogy from another mode of HIV transmission. A
blood transfusion or a transfusion of fresh-frozen plasma is like
having sex with several people. Receiving a single dose of a plasma
product is like having sex with up to 10,000 people.

If the plasma is
from an open market source then those thousands of people may well
include many injecting drug users and others at high risk of carrying
transmissible infections, because the incentives in the market
promote acceptance of the highest possible number of donors and their
payment at the lowest possible price. Furthermore some or all of the
sex might have been unprotected.

Even with all
mandated safety procedures followed in full, the US government
calculates a residual risk of HIV, HBV or HCV infection of 1/15,662
for a unit of plasma from a voluntary unpaid donor, and 1/10,959 from
a paid donor. The 43% higher risk associated with payment of donors
arises because of higher incidence of blood-borne disease among paid
donors. The fact that payment for blood was associated with
increased risk of infection compared to volunteer blood was
established in 1959.16

This risk profile is
not ideal but is arguably acceptable for a patient with a
life-threatening condition. The problem is that the precautions are
too often not observed in product made for the open market, because
skimping on them or neglecting them entirely keeps costs low.

The government
regulator of the US plasma industry stated in 1998 that

“instances of companies’ non-compliance with good
manufacturing practices have

been many”.

Such lapses continue in the global industry17,18,19.
As Dodd comments concerning blood safety in China,

“shortcuts, shoddy practices, the pursuit of the bottom line and
a lack of oversight can have devastating outcomes”20.

Growing demand for plasma globally, and the
coming IVIG boom

The demand for
plasma products has been increasing by about 10% per year, 14% for
some products. The range of uses continues to expand, with not only
purification of new therapeutic proteins, but identification of new
uses for existing product lines such as IVIG.

IVIG has proven uses
in replacing absent antibodies in immune failure and immune
deficiency disorders. It is now used, at much higher doses, in
situations where doctors believe that anti-inflammatory action by
IVIG averts damage from the patient’s own immune response, as in
septicaemia, transplantation reactions, and a number of autoimmune
conditions.

According
to the International Patient Organisation for Primary
Immunodeficiencies:

“Despite
the high cost of plasma products therapies, the demand for these
products has increased in every region, and it is expected to
continue to grow in the years to come. As a result, higher volumes of
plasma will be required in the future.”21

The first product
license for IVIG was obtained by Cutter Biological in 1981.22
IVIG, is in particularly high demand and already sells for more,
weight for weight, than the price of gold, while being inexpensive to
produce. This profit profile is not lost on investors, hence the
plasma production market is constrained not by availability of
capital but by availability of safe plasma. IVIG can be produced only
from human blood.

The 14% growth
figure is used below to extrapolate the global consumption of IVIG
from 1984 to 2008 into demand up to 2014: this suggests the supply is
likely to become seriously constrained by the availability of plasma,
with a great deal of unmet demand.

This growth pattern
is linked to the fact that IVIG is now widely used in developed
countries for "off-label” applications, most of which lack
evidence of effectiveness to justify their use. A plasma
industry-sponsored 2003 study in Canadian hospitals found 53% by
volume of off-label use of IVIG in treating adults, and 38% in
paediatric treatment. Of the 90 different uses identified, 84 were
“off-label”, that is, not evidence-based.

In a 2008 review of
the academic literature identifying more than 150 unlabeled uses of
IVIG, the authors warned:

“An examination of IVIG guidelines by specialty society, payer, and other review organizations revealed that the biomedical evidence supporting off-label uses is being interpreted in different ways. Health care institutions are strongly urged to approve and closely monitor specific uses of IVIG to reserve dwindling supplies for the “best-evidence” uses.

Clinicians should be aware of the limits of knowledge in many off-label uses and exercise restraint in prescribing for unproven indications.”23

The use of plasma
products to treat ever wider groups of patients also means that any
future contamination could threaten far more patients than ever
before. For instance IVIG is now being used for childhood asthma, and
a new IVIG trial is underway for reducing obsessive-compulsive
disorder (OCD) symptoms in children.26
Other recent research suggests use of IVIG for neuropathic pain,27
which is unpleasant but not life-threatening and for which other,
safer, treatments exist.

Despite consisting
of antibodies, infection transmitted through IVIG has been
documented: though it does not transmit HIV or HBV easily, HCV may
survive the production process, for instance:

A notorious investigation involved Gammagard, manufactured by
Baxter. This product was temporarily withdrawn from the market in
1994, after reports of over 200 cases worldwide of HCV transmission
related to multiple lots. The risk of transmission to recipients
(11%) was striking.

Baxter was screening donors using an, at the time, new
second-generation HCV antibody test, and the loss of donors with
neutralizing and complexing antibodies to HCV could have resulted in
a higher load of virus. In addition, all implicated IVIG preparations
were lyophilized [freeze-dried], which might have allowed
greater stability of HCV virions.

Finally, the source of donor (paid for Gammagard vs. volunteer for
Polygam) might have affected HCV infectivity in the pools.28

As well as
infections passing through IVIG, severe adverse events can be
associated with its infusion, including aseptic meningitis, stroke,
heart attack, and death from anaphylactic shock. These outcomes are
more common with products that are freeze-dried or contain high
levels of sugar or salt.[11]

The Australian
government prioritises child patients for IVIG made from its own
national volunteer programme, on the grounds that products acquired
on the open market are less safe.29

Williams et al
highlight the fact that pooled antibodies from one person may attack
antibodies from another, recognising them as unfamiliar. This can
trigger the clotting cascade, resulting in aggregates forming which
have been connected with clot formation leading to potentially fatal
anaphylactic shock, strokes and heart attacks. The probability of a
bad reaction in the patient is related to the quantity of such
aggregates found in the IVIG injected, which were measured to be from
5% to 18% of the antibody content.31

Despite these
considerable medical risks attached to each dose of IVIG
administered, writers in the field have noted that not only are new
applications for IVIG continually being suggested, the case
definition of some conditions treated with IVIG seems to be widening
dramatically. For instance, patients diagnosed with Primary Immune
Deficiency (PID) used to have “life-threatening osteomyelitis,
meningitis, and lobar pneumonia” but nowadays often have only quite
minor problems such as ear and sinus infections, mild pneumonia, or
diarrhoea.32

It should be noted
that access legislation in the USA has been passed to entitle people
over 65 diagnosed with this new expanded definition of PID to have
federally-funded IVIG therapy:

“(December 20, 2012) — The Plasma Protein Therapeutics
Association (PPTA) applauds the House of Representatives on
yesterday’s passage of the Medicare IVIG Access Act (H.R. 1845),
which gives Medicare patients who suffer from primary
immunodeficiency disease (PID) better access to lifesaving
intravenous immune globulin (IVIG) therapy at home. “House passage
of this bill is a victory for patient access to lifesaving IVIG and a
testament to the steadfast commitment of the Immune Deficiency
Foundation,” according to Julie Birkofer, Senior Vice President,
North America.

The bill introduced by Representatives Kevin Brady (R-TX) and
Doris Matsui (D-CA) establishes a three-year Medicare demonstration
project that provides reimbursement for the services required for
home infusion of IVIG by PID patients.”33

It is worth noting
that this affects only Medicare-funded patients, all of whom are over
65 and thus in the high risk group for dangerous reactions to IVIG.

Constrained supply of safe plasma

Rising international
demand for plasma products, due to new medical uses and intensive of
cutting-edge immune therapies, is likely to outstrip supply and lead
to increased shortages. For many there was by 2012 already an
increasing shortfall.35
This creates incentives to exploit all sources of plasma, and to
operate lax donor selections standards.

Only a few developed
countries allow the purchase of plasma which is essential to enable
commercial exploitation, so there is great demand for their output.
Many studies36,37,38,39,40,41
suggest that voluntary unremunerated donors show lower blood-borne
infection rates than do paid donors. Other research42,43
demonstrates that paid donors are more likely to suppress
information about high-risk practices which would exclude them from
the donor pool if disclosed. The offer of payment thus results in an
increase in unsuitable donors drawn by the money who are reluctant to
drop out if requested to do so for health reasons because that
requires reducing their income.

China’s plasma seller HIV outbreak caused its government to take
action against breaches of good manufacturing practice in this
industry. The consequent contraction in supply has resulted in
insufficient plasma to meet China’s own ever-rising demand and the
global commercial appetite for its plasma product exports. In August
2007, the state press reported supply interruptions for albumin at a
Shanghai hospital. Available supplies met only half the demand, and
were rationed to those patients in greatest medical need.

One major supplier, Shanghai Institute of Biological Products,
repeatedly sold out of the limited production that it could make from
the output of those plasma collection stations which survived the
recent closures on public health grounds. The 2007 raw materials
supply of this manufacturer was only a quarter of its 2006 supply,
suggesting that in 2006 three-quarters of its supply may have been
unsafe44.

The plasma shortage has already hit China’s haemophiliac population
of 60,000-100,000. Previously around a quarter of this group were
able to afford Factor VIII to prolong their lives (China has
market-based national healthcare so it is up to patients to fund
their own treatment). Some of those haemophiliacs who had been able
to afford treatment have died since July 2007 because of Factor VIII
supply interruptions45.

Black and grey markets thrive where supply and demand in regulated
markets are unbalanced, as commercial suppliers can profit by
sourcing illicit supplies. So this excess demand in the market is
not good news for patients.

In theory the failings of a market can be compensated by regulation.
However if there are significant commercial incentives to break the
rules, watertight regulatory control becomes prohibitively expensive
and finally unachievable. The imposition of any significant
penalties, or even a requirement to desist from unsafe practice, sets
up potential for corruption among the inspectorate, as the companies
have incentive to pay the inspectors not to inspect up to the amount
that it would cost them to comply with good practice. In other words,
the market directly incentivises corruption.

Thus the inspectors themselves need independent regulation to ensure
that they are not paid to turn a blind eye, and so on. When even the
late head of the Chinese State Food and Drug Administration46
found it impossible to resist payments from pharmaceutical companies
to pass substandard medications, it seems unwise to rely on the
incorruptibility of blood safety inspectors to protect us when the
profits to be made from the plasma trade create such strong
incentives to break the rules.

The added risks of buying plasma products on
the open market

Many
tens of thousands of people in many countries have been killed by
fatal diseases transmitted through plasma due to inappropriate donor
selection, collection and processing arrangements. Markets in raw
plasma and in plasma products systematically and inevitably create
perverse incentives contrary to patients’ interests.

A US journalist reported the 2007 financial incentives in the plasma
industry in a province of China47:

Thus everyone
concerned has a financial interest in maximising the quantity of
plasma collected. The corollary of this is that everyone has a
financial interest in concealing information on substandard plasma
and known or suspected infections.

A seller of his or
her own plasma, and any middleman, wants to sell the maximum amount
of plasma for the maximum price. At every stage in the supply chain,
a buyer of plasma wants to buy the maximum amount for the minimum
price. Both agree on maximizing the amount which is sold. This
creates an incentive for both to suppress information exchange about
possible infections and to avoid screening: both stand to gain by
putting potentially unsafe raw material into the system.

The bigger the
plasma pools are, the cheaper they are to process, but the riskier
they are for patients for both infection and for death through
stroke, heart attack or anaphylaxis. Use of larger pools multiplies
the risks attached to collection methods which are vulnerable to
including infected plasma.

Maintenance of
infection control in relation to equipment generates risks to
patients in a similar way; cleaning takes time, and reusing
disposables saves time. Hiring appropriately qualified staff and
training them properly takes time. In business, time is money, and
money saved is money made.

In a competitive
market, the lowest price producer will find it easy to sell all of
its production, but competitors offering product at a slightly higher
price may attract little custom at times of low demand. Blood
products have limited shelf -life, so if they are not sold they
cannot be stockpiled to await higher prices but must be discarded. A
few pence reduction in the selling price can be the difference
between many sales and having to throw away most of the production
because it has passed its sell-by date. It may be far cheaper to cut
corners on screening and processing then bribe the inspectors than to
carry out the procedures properly.

There are thus
intrinsic dangers in allowing commercial interests into blood
processing. The first duty of a commercial company is to make profits
for its shareholders from their invested capital. Minimising costs
is the easiest way to maximise short-term profits; while this
promotes “economic efficiency”, in this sensitive context it can
threaten safety.

Market models assume
that everyone involved has “perfect information”, full knowledge
of all relevant information. This is one of several reasons why
market economics is generally irrelevant to healthcare. Market
advocates insist on assuming away the fact that the ultimate consumer
of a plasma product is entirely unaware of whether the vial in his
hand may be infected with dangerous viruses or not. The patient
carries all the risks created by the incentives for producers to
increase their incomes by reducing expenditure on infection control
and good manufacturing practice.

Thus use of markets
in producing and supplying plasma products directly puts patients at
risk of life-threatening infections and medical emergencies.

Frontline reports from the global plasma trade

There is an alarming
history of incidents showing the dangers of trusting the
international commercial plasma market, with diseases being spread to
patients on the other side of the world from the plasma source, and
unsafe practices sometimes continuing for years after their risks
were well understood.

Thousands of people
in many countries have been killed by fatal diseases in plasma due to
inappropriate donor selection, collection and processing
arrangements. Most of the major corporations involved in plasma
processing have been implicated at one time or another in scandal due
to alleged failures in quality control.48

A brief review
follows, explaining relevant events and arrangements in four
countries, all of which themselves consume plasma products. The first
three countries, Germany, China and the USA all allow plasma purchase
and are major plasma products exporters. Canada provides a case study
of the workings of plasma brokers and the potential consequences of
relying on imports. These are a few illustrative examples:
unfortunately the catalogue of catastrophes which follows covers only
a small part of the history of problems arising from the plasma
trade.

1. Germany

Germany permits
purchase of plasma and thus has a commercial plasma products
industry.

From the 1970s there
have been accusations that doctors with private commercial interests
in clotting factor production were over-treating and
under-supervising their haemophiliac patients, greatly increasing
their risks of contracting infection. One German hospital alone used
more Factor VIII than the whole USA, and an average German
haemophiliac received up to four times as much donated clotting
factor as the typical American haemophiliac. A single patient cost
the German state more than $4 million per year to pay for his
clotting factors, purchased by the government from his treatment
centre on a for-profit basis in a major conflict of interest.49
This high level of prescription was lucrative to the plasma
processors but multiplied the infection risk to patients.

In Germany unsafe
practice at harvester UB Plasma over some years resulted in HIV
infections:

“At
least 60 hospitals and clinics across Germany received blood products
from UB Plasma or several intermediary firms, according to health
officials. Some products also were exported to Austria, Saudi Arabia
and Greece.

According
to health officials and German press accounts, UB Plasma apparently
failed to test two-thirds of its donated blood supply in some cases.

A
spokesman for the Social Affairs Ministry in the western German state
of Lower Saxony said yesterday that "we operate on 120,000
people a year. Over 10 years that means up to 1.2 million people are
potentially affected by the call to be screened. Further complicating
matters is the discovery by some hospitals that many - perhaps most -
patient files do not indicate whether the blood products originated
with UB Plasma.”50

“The
Koblenz-based firm UB Plasma was closed down two weeks ago and four
workers were arrested over allegations of improper testing, and there
are fears that tainted plasma may have been sold to about 80
hospitals in Germany and elsewhere in Europe.

The
first two cases of patients infected with HIV due to the use of UB
Plasma products were confirmed yesterday, officials said in
Koblenz.”51

The four employees
were “accused of knowingly using unreliable testing methods on
blood to save money”,52
then ignoring information that some donors were HIV+.53
In addition, UB Plasma collected one and half tonnes of plasma in
Romania which was impounded by the Romanian government because no
screening at all was used. A subsequent government released it and UB
Plasma sold it into the global supply chain.54

In 1995, the German
authorities shut UB Plasma down and imprisoned its senior managers.
One possible purchaser of PR UK, Biotest, was drawn into the scandal,
which resulted in its licence being withdrawn:

"German
Firm Ordered to Pay AIDS Compensation" Reuters (05/02/94)

A
Bonn court yesterday ordered German pharmaceutical firm Biotest to
pay more than $150,000 to a 13-year-old boy who became infected with
HIV through contaminated blood products distributed by the company.

That
amount, in addition to compensation arising from the firm's medical
liability, placed the total award at about $240,000, according to a
Biotest spokesperson.

The
pharmaceutical company was linked to a national scandal that surfaced
last year when another company, UB Plasma, was found to have
distributed unscreened blood products that were given to millions of
people nationwide for more than a decade.

Biotest,
as one of the distributors who bought blood from UB Plasma, had its
license to make the blood products suspended. The court ruled that
the company did not prove that it had not shown lack of due diligence
when the hemophiliac youth was infected during routine treatment in
1989 with a preparation derived from HIV-tainted blood.

Biotest has
already settled out of court with 10 other patients who were infected
through the same batch of blood.55

2. China

Poor infection
control in the Chinese plasma industry caused a huge scandal which
still affects China’s new Premier Li Keqiang.56
Lack of plasma seller screening and other infection control breaches
in “entrepreneurial” plasma collection centres led to an enormous
outbreak of blood-borne disease which infected tens of thousands of
plasma donors and recipients with HIV, HBV, HCV or some combination.

Over the years,
various methods have been used to ensure collection of sufficient
blood to meet China’s demand, commencing with cash payments to
donors who were often homeless migrants. Blood station staff
organised middlemen ("blood-heads") to liaise between the
blood bank and professional donors of no fixed abode.57
Similar arrangements were used in post-war Japan, until a
syphilis-infected transfusion caused a national scandal and the
government set up a safe supply chain.

A self-perpetuating
commercial system resulted from the Chinese blood-head initiative
which soon turned to supplying the lucrative plasma trade with raw
material. Its influence saw the quality of plasma fall as the
quantity harvested in total and from each individual rose, the
blood-heads maximising their incomes by administering medicines to
plasma sellers to increase blood volume and conceal disqualifying
medical conditions so as to maximise the amounts sold.58

In 1994 and 1995,
Chinese media reported children and destitute adults abducted and
bled of plasma daily against their will by criminal gangs.59
Plasma donation should not be more than fortnightly for the health of
the seller and the quality of the product.60
Too-frequent harvesting can cause malnutrition from protein
depletion, and kidney damage.

Plasma sellers were
repeatedly bled and given a mix of pooled cell fraction from donors
of the same blood type instead of receiving their own cells back.
Injecting drug users were transported by middlemen around the country
to wherever the middlemen could make the most money by supplying the
donors to collection stations. Since their blood entered the pool,
other plasma sellers became infected with blood-borne infections
mixed with the returned cells.

Even outside
plasma-selling areas, 10% of the PRC’s population carry HBV. An
additional 50% have been acutely infected and recovered without
developing a carrier state, but these cases would be infectious if
their plasma were harvested just after initial infection before
jaundiced eyes and skin became apparent. That could also be during
the initial test window period so that infection could pass
undetected into the blood supply despite correctly executed screening
protocols.

In China, illicit
collection continues in some areas, driven by profit opportunities
and enabled by the expense and difficulties of watertight regulation.
In September 2006, the Guangdong Bioyee Pharmaceutical Company was
found to be running an illegal collection facility65,66
despite passing routine inspections by the Guangdong health
department. Hepatitis C was diagnosed among patients treated with
the company’s “human gamma globulin” IVIG preparation.67,68
The State Food and Drug Administration (SFDA) has since revoked its
operating licence and certificate of Good Manufacturing Practice,12
as the virus would have been destroyed if correct procedures had been
followed.

Tighter government
controls were applied to purification of antibodies from June 2007
and to albumin from January 2008, following an investigation of the
widespread sale of fake albumin.69
The SFDA announced that provincial authorities have assigned 84
quality supervisors to cover China’s 33 blood products
manufacturers and also 32 vaccine makers.70
This will constrain the global plasma supply if enforcement is
effective, and will make it more hazardous if supervision fails and
“entrepreneurs” are able to boost the plasma supply once again to
responds to the perverse incentives inherent in a commercial system
for producing plasma products.

Blood products made
from Chinese plasma now supply the global market71;
for instance, the Sino-American joint venture Shanghai RAAS72
exports to English- and Spanish-speaking markets. Other foreign
plasma fractionation companies also seek to undertake production in
China, to serve both Chinese and global markets.73

3. USA

Following a spate of
“thromboembolic events” (strokes, heart attacks and clots on the
lung) in users of Octapharma’s IVIG product Octagam,74
a 2011 exchange75
from the staff blog of a US plasma products manufacturer illustrates
the implications of the risk-promoting perverse incentives inherent
in any market for infection-transmitting human tissues:

“Re: thromboembolic events, recalls and Noncompliance - oh my

Regardless of what happens with the Grifols/Talecris merger - at
least the plasma supply will be cleaner without Octapharma. Bad OPI
plasma and drug could bring the whole industry down a notch. Is
anyone really looking at how long that stuff is out of the freezer
during morning packing?”

“Re: thromboembolic events, recalls and Noncompliance - oh my

“Nope no time record. The FDA will see that. It could be out
for more than an hour and no one would notice. For that

matter, no
one really keeps track of how long it is sedentary after it's
collected. Some of the centers don't use timers so who knows how long
before it's frozen. It gets shipped hemolyzed, icteric, and lipemic
just the same.”76

These postings appear to imply that Octapharma
did not comply with adequate infection control systems, good
manufacturing practice, or quality control of output. They also seem
to suggest that the company had omitted even to set up the mechanisms
needed to achieve acceptable standards, such as timers to monitor the
time that plasma spends outside the freezer. The titling shows that
the company’s staff link these failings with serious adverse events
found at elevated rates among Octagam users.

Further compliance problems at Octapharma are
identified in this staff blog,77
including misrepresentation investigated by US regulators:

CBER's Office of Compliance and Biologics
Quality reviewed a card file and dosage guide for Octagam 5% [Immune
Globulin Intravenous (Human)], which were disseminated at the
Octapharma booth at the American Academy of Allergy, Asthma and
Immunology meeting in San Antonio March 18-22. The agency also
reviewed the company's website and determined the file card, dosage
guide and website were misleading because they failed to reveal the
risks and contained unsubstantiated safety, effectiveness and/or
superiority claims.71

Some excerpts from
the history of the US plasma trade will illustrate the frequency and
seriousness of the problems.

One of the big
plasma traders, Cutter Biological, now owned by German plasma
processor Bayer AG, was sued by an Arizona prisoner in 1980 for
contracting blood-borne hepatitis from selling plasma at a prison
collection site that Cutter ran from 1966 to 1987.78
Although it can hardly thus have been unaware of the infection risks
connected with its sources, Cutter responded to the 1983 warning and
the 1984 discovery that heat treatment of clotting factors could
eliminate HIV by issuing reassurances and continuing to supply
non-heat-treated product to haemophiliac customers instead of
informing them that for safety’s sake they should transfer to a
competitor’s product while it started up a new safer production
line.

Cutter continued to export remaining stocks of unsafe product to
haemophiliacs in Latin America and Asia after it started its own
safer production line in February 1984. It has been alleged that into
1985 it continued parallel production without the new safety protocol
in order to service fixed price contracts at lower cost to the
company, causing more than a hundred deaths in Hong Kong and Taiwan
and an unknown number in Malaysia, Singapore, Indonesia, Japan and
Argentina.

Three other
companies (Armour Pharmaceutical, Baxter International and Alpha
Therapeutic) also continued to sell unheated concentrate after the
risks were understood and a viable heat-treatment process was
available. They allegedly continued until the risks has become so
widely known because of lawsuits that there were no more customers
for untreated clotting factors.79

The President of Alpha Therapeutics resigned in 1983 because he
believed that the company’s products were unsafe but Alpha’s
parent corporation were not addressing the problem.80

It required
legislation in the USA to stop the market leaders harvesting plasma
from alcoholics, addicts and derelicts on Skid Row, whereupon plasma
processors relocated to the Caribbean, Central America and Africa to
set new low prices and exploit previously untapped under-classes. In
Haiti, the US joint venture Hemocaribean paid $3 per litre (the
human body contains 4-5 litres of blood).

Following the 1974 warning of the International Red Cross
Inter-American Conference about

“this new modality of exploitation of the most needy, a
dangerous, scandalous and unfitting traffic” ,

the World Health Organization asked developing countries about their
involvement in plasma harvesting. Eleven of the twelve replies they
received recorded approaches by commercial firms.81

Most developing countries eventually evicted the plasma industry as
exploitative and dangerous. Even Haiti’s dictator Baby Doc Duvalier
felt that these plasma harvesting operations breached the limits of
acceptable conduct and ejected them.

In Nicaragua, abuse of the population by plasma harvesters triggered
the 1978 revolution.

In March 1983,
the US Center for Disease Control reported that blood products
transmit HIV, and in October 1984 it announced that 74% of
haemophiliacs who used unheated clotting factor concentrate had
already contracted HIV from blood products.82

Institutional
settings such as prisons facilitate easy and cheap collection of
large-scale supplies of plasma for processing, and they are better
than Skid Row for managing sellers because prisoners rarely
unexpectedly disappear, unlike vagrants and addicts. This
economically efficient option magnifies risks because everyone in
the supply chain has an incentive to bend the rules so that everyone
makes money; the patient’s interests go unrepresented.
Consequently, repeated breaches of security procedures have
occurred.

Further, prison populations tend to have much higher rates of
blood-borne diseases than the general population due to both the
characteristics of their intake (proportion of injecting drug users,
for instance) and behaviour inside prison such as tattooing,
injecting with shared equipment, and forced sex.

It has been known since a published study in 1966 since that HBV
rates in the USA are roughly proportional to the proportion of the
plasma supply derived from prison populations.83
A 1958 study showed that prison donors were about ten times more
likely to carry HBV than volunteer donors, but its results were
attacked by the plasma industry who correctly perceived that if the
findings of this study were taken to their obvious conclusion in the
USA, the government would set up the volunteer-only non-commercial
blood supply that most developed countries aspire to and their profit
stream would vanish overnight. The US Food and Drug Administration
met representatives of US fractionators in December 1982 and told
them not to use prison plasma.84

Plasma harvesting in Arkansas prisons from the 1960s to 1994 was
responsible for thousands of deaths in at least ten developed
countries and unknown numbers elsewhere. The prison programme in
poverty-stricken, drug-addicted Grady, Arkansas harvested plasma from
hundreds of inmates. Cutter Biological ran the collections from 1963,
then from 1979 a local company, Health Management Associates Inc.
(HMA) took over. HMA sold the plasma to brokers on the open market
who resold it to plasma processers.85

The FDA first noted infringements by HMA at Grady in July 1982:
prisoners were “over-bled” and there was no evidence that HBV+
contributions were being destroyed as required.86

In 1984 the prison’s output was banned for use in the USA because
the FDA found blood-borne hepatitis in HMA plasma and linked it to
twelve HBV+ donors. Investigation revealed that an inmate had been
put in charge of infection screening. Predictably, he took advantage
of his position to earn extra money by selling a screening test
bypass to prisoners banned from donating because they had previously
tested positive for HBV, to allow them to continue to receive an
income from selling their plasma.79 HMA Inc lost its
licence temporarily but was then permitted to restart “for the good
of the inmates and the prison” (according to Francis Henderson MD,
paediatrician who started HMA) when the corrupt clerk was moved on.

HMA continued exporting until it lost the prison contract and
consequently shut down in 1986 after a critical 1985 report by the
Institute for Law and Policy Planning. By that time HMA had lost its
licence three times, but the Arkansas Bureau of Corrections continued
to give it the plasma collection contract for the prison despite bids
from more reputable companies.

Pine Bluff
Biologicals was contracted to replace HMA at Grady; in 1998 its
owner expressed the extraordinary view that:

“There is this whole thing about the high-risk population. I
disagree with that. There’s no scientific proof to that.”

His comment on precautions taken against HIV appears to indicate lack
of knowledge of the role of injecting drug use and other
skin-breaching practices in spreading HIV, or the high prevalence of
injecting drug use among both the local population and inmates:

“If anyone got caught in a homosexual act, we took them off the
roster,”

Plasma collection in Arkansas prisons continued until 1991 under the
control of this company, then was run by a third company until no
customers at all could be found in 1994.79

Products made from these prisoners’ plasma were implicated in
Hepatitis C outbreaks in Canada,
87
France, Iran, Iraq, Ireland, Italy, Japan, Portugal, Spain, Scotland,
Switzerland and the USA88,89,
all resulting from market purchases of plasma products. The Clintons
were part of the Arkansas administration for much of this period, and
it has been alleged that they interceded to protect the plasma
collection facility.80.

Prisoners in Arkansas were banned from earning money from the labour
they undertake (this is the only US state to have such a ban) but
were permitted to sell plasma for $5-$10 a pint. The prison sold it
on for $50 a pint, earning over half a million dollars a year in some
years.80

A selection of comments from those involved in this programme
illustrates how it was run79:

“I
could see [prisoners]
were being given illegal narcotics — several indicated that this
was how they were being paid for their plasma.” [Inmates]
“appeared jaundiced and very sick. When I would ask if they had
just had a blood test, they would say, ‘No, I’ve just given
plasma.’ It was clear they were sick.” “I assumed, stupidly,
that our people selling this plasma had some process of cleaning it
up.”

“ [People
in HMA] management
positions…initiated or condoned the destruction or alteration of
records concerning these activities.”

(US
Federal Drug Administration Report, 1984)

“The
prison program they had was pretty shoddy, they had inmates doing
things they shouldn’t have been doing. They would let people who
was sick bleed … ain’t no telling what they had. They didn’t
check all the time.” “I am damn sure I got it [hepatitis
C]
in the prison, I didn’t have it before I went in. I have never had
needles stuck in my arm that wasn’t supposed to be there. I have
never interacted with homosexuals. I love women too much. I didn’t
get it those ways.”

“After
a promotion, an inmate who became my clerk told stories of events
that took place when he was assigned to the plasma center, including
things like the refrigeration going out for hours and the plasma
being refrozen later and shipped.”

“There
was a mentality that we didn’t have any AIDS in the central part of
the country. The department (of corrections) said for years we didn’t
have any AIDS cases. There was a subconsciousness that we just didn’t
want to think we had those people around us. Historically, this [was]
the worst possible time to [sell
plasma – because prison plasma was now banned in the USA and most
buyers no longer wanted it].
I called all over the world and finally got one group in Canada who
would take the contract.”

Some of the Arkansas blood infected UK haemophiliacs because the UK government
bought plasma products that could not be supplied domestically on
the open market. According to the enquiry on infection of UK
haemophiliacs conducted by Lord Peter Archer:

[A] significant burden of responsibility [for tainted blood
provided to British hemophiliacs] rests on American suppliers of
Factor VIII concentrate. Long after alarms had been sounded about the
risks of obtaining paid-for blood donations from communities with an
increased incidence of relevant infections, such as prison inmates,
this practice continued.

It is difficult to avoid the conclusion that commercial interests
took precedence over public health concerns.93

In 2008, about 70%
of the global plasma supply was purchased in the USA.95
US law makes it hard to sue for infections contracted from the US
blood supply because of special “blood shield” laws.96

4. Canada

In Canada, the
government was nearly brought down97
when it became plain that at least 30,000 patients caught hepatitis C
and 1000 contracted HIV during the late 1970s or 1980s from
transfusions and blood products.98

The Canadian Red
Cross did not know that clotting factor preparations it bought
through recently privatised Toronto-based Connaught Laboratories were
made from HMA’s Arkansas prison plasma. Canada had itself stopped
collecting from prisons in 1971 because of the infection risks.
Montreal commercial plasma broker Continental Pharma Cryosan was the
source of the HMA plasma used by Connaught Laboratories.

Connaught had ceased
doing its own checks on plasma in favour of relying on US Food and
Drug Administration reports. The 1997 Krever Commission which
investigated the outbreak among Canadian haemophiliacs discovered
that Connaught had accepted consignments of blood rejected by the US
authorities:

"The Food and Drug Administration inspection reports were obtained, but they were not reviewed....According to Magnin [Dr. Anthony Magnin, former director of plasma fractionation at Connaught], it didn't register with Connaught that it was using blood from the Arkansas Department of Corrections until August,1983 - six months after the company was informed. Magnin, who testified that collecting blood from prisoners "was not considered inherently a problem" by Connaught, admitted that "either the documents were not read" when they were received "or they were read and not acted upon." 79

“Evidence has indicated that checks to safeguard Connaught's blood products against AIDS or hepatitis infection appear to have been almost entirely absent during the early 1980s.”

According to the
Commission:

"There was a greater than average risk that the 38 units of
plasma from the four inmates [identified as HBV+ in 1983]
could transmit AIDS. Four of the units ended up in Canada, the others
were sold to corporations in Switzerland, Spain, Japan, and Italy [by
Cryosan]."99

“The shipping papers accompanying the plasma had not revealed
that the centre was located in a prison. They had simply referred to
the source as the ‘ADC Plasma Center, Grady, Arkansas,’ without
any indication that ‘ADC’ stood for ‘Arkansas Department of
Corrections.’

“In a letter to the Red Cross in March, 1983, a senior
Connaught official assured the blood agency that that none of its
plasma suppliers was "located in population centres in the U.S.
shown to bear high risk for AIDS."

However, a month
earlier, Connaught's quality control department had received
documents that clearly showed plasma was being collected from prisons
in Oklahoma, Texas and Arkansas and sold to Connaught through various
brokers.

Further evidence yesterday indicated that, when the
developed world began turning to heat-treated blood products,
Connaught began eyeing less developed countries as likely markets for
its non heat-treated ones.

In confidential Connaught memos
from October, 1983, Iran and Spain are mentioned as possible markets,
and there is speculation the laboratory "could be in a position
to sell 6 million units to France." In a later memo, however,
Connaught apparently decides against selling to France, specifying
that "current product should not be offered for sale to
developed countries."100

Former Canadian
Prime Minister Paul Martin has been touched by the scandal because of
his role in the Canadian Development Corporation which was supposed
to oversee the activities of Connaught once it started to be run for
profit.101

In September 1983
Connaught reviewed its records and determined that twelve of its US
sources were never approved. Among them were the Grady prison and
four Louisiana prisons. The Canadian Red Cross cancelled its contract
with Connaught on discovering this, but too late for many
haemophiliacs and their wives, already infected by contaminated
clotting factors.

Continental Pharma
Cryosan had a prior record of unacceptable practice which should have
been grounds for Connaught to reject it as a supplier. Following a
Canadian police investigation, in 1980 the company entered a guilty
plea for labelling blood as sourced from Swedish donors which had in
fact been extracted from Russian corpses.102

In the early 1990's
The “Committee of Ten Thousand” activists claimed compensation of
up to $100,000 apiece with a total settlement of $1 billion sought in
1999.103
The companies they were suing (Baxter, Bayer AG, the US subsidiary
of French Rhone-Poulenc, and Japanese-owned Alpha Therapeutic
Corporation) announced a settlement for Japanese haemophiliacs
infected by Arkansas plasma that dwarfed the numbers being discussed
in Canada: $420,000 for each victim, with $235,000 coming from
industry and the rest from the Japanese government. 104

In the end Ontario’s
settlement alone cost the province $1.2 billion.105

Unfortunately
the UK no longer has the option of self-sufficiency in plasma supply,
as a consequence of the decision by the Conservative government to
deregulate the cattle feed industry. The producers stopped
heat-sterilising the sheep remains they were putting into cattle
feed, and British cattle developed a never-before seen disease,
bovine spongiform encephalitis (BSE or “mad cow disease”) which
turned out to be derived from the long-known sheep brain disease
scrapie. The meat from infected cattle went into the UK food supply
and the disease leaped a second species barrier: it turns out that
scrapie is not directly infectious to humans but once the infectious
agent passes through cows at least some people who eat it develop an
incurable, untestable, untreatable disease. This turned out to be a
new variant of Creutzfeldt-Jakob Disease (vCJD), which kills
following a decline into madness as brain tissue disintegrates over
several years.

So
far 175 people have contracted it in the UK and 49 elsewhere
(diagnosed
between October 1996 and March 2011).106
It was declared unsafe to use UK plasma in 1998 because of the risk
of it being contaminated with vCJD, for which no screening test is
available. The World Health Organization has this to say on the
challenge of determining the risk from vCJD in an infected
population:

The
maximum duration of infectivity in blood of persons with
pre-clinical/sub-clinical vCJD as well as the prevalence of
pre-clinical/sub-clinical vCJD in various countries is not known.
Consequently, the long-term risk of transfusion-transmitted vCJD for
donors exposed to BSE agents in various countries is not known.107

In 1994 a US blood
donor died of vCJD and all UK-derived plasma products in the USA were
recalled. In 1998, the UK government stopped using UK plasma and
started buying plasma on the US open market.108

The Australian
government limits vCJD risk within its national plasma supply by
opting to

“exclude people from donating who have resided in the UK between
1 January 1980 and 31 December 1996 for a total (cumulative) time of
6 months or more, or [who] have received blood transfusions in the UK
since 1 January 1980. Because of the extensive time period covered by
the deferral and the possibility of unknowing exposure to beef or
beef products, it is not possible to exempt vegetarians who have
resided in the UK for a cumulative period of 6 months or more during
the risk years. The Blood Service is monitoring progress in the
development of a reliable blood screening test for vCJD.”109

How was a sustainable second best achieved? UK
government response phase 1

In order to secure a
sustainable and reliable safe supply of plasma and blood products for
the UK’s government-owned plasma processor Bio Products Laboratory
(BPL), in 2002 the Department of Health purchased the largest
remaining independent US plasma collector.110
At the time commercial plasma processors were buying up plasma
harvesters and so the open market supply of plasma in the US was
shrinking. The company is now known as Plasma Resources UK; its
current market products include blood-clotting factors for
haemophiliacs and ingredients for vaccines for rabies and hepatitis.111

This
was a wise and sustainable solution to the problem, though far
inferior to having the safe pool of UK donors denied to us by BSE.

Eleven years later the uses for plasma have multiplied, the amounts
used in the UK and around the world are soaring, and the second
largest source nation, China, has been forced to reduce exports
because of repeated infection breaches among producers. Thus the
reasons are stronger than ever to keep this government-controlled
producer and reserve its production for the British people.

The
government seems to be ignoring both this quantity-based argument for
maintaining a nationally controlled supply of safe plasma, and the
more fundamental quality issue that profit-led open market plasma
producers inevitably devote themselves to buying cheap and selling
dear in an environment where the final user has no protection from
abuse by the supplier.

The impending destruction of that second best:
UK government response phase 2

The
Health and Social Care Act 2012 explicitly permits the privatisation
of our national supply of blood, plasma products, tissues and organs.

In
October 2011, the Health Service Journal reported that
part-privatisation plans for UK blood and transplant services had
been dropped. NHS Blood and Transplant was temporarily reprieved
because of protests about a hovering would-be provider, Netcare, a
South African company implicated in illegal kidney transplants from
minors.

The
government are keen to pass the second of these categories, plasma
products, over to a commercial plasma producer. PR UK was turned
into a limited company by this government in 2012 and now been moved
out of NHS Blood and Transplant to be run directly by the Department
of Health (DH).
This facilitates its sale to the highest bidder and allows the
government to continue to claim that none of the functions of NHS
Blood and Transplant will be privatised.

Health
Minister Simon Burns last July announced that PR UK would be
privatised,113
and appointed Lazards, an investment bank chaired by Lord Peter
Mandelson, to oversee the privatisation. International companies are
currently placing their bids and a deal is likely to be finalised by
June114.
It emerged in January 2013 that the Spanish plasma producer Grifols
SA was the UK government’s preferred bidder for PR UK, but Grifols
has declined to purchase, on the grounds that PR UK’s US market
presence added to its own would be of sufficient size to trigger a
competition law (anti-trust) dispute in the USA.115

Reportedly116
American companies including scandal-hit Baxter International and
private equity firm Bain Capital have submitted bids, and the German
company Biotest AG117
is said to be interested. In 2002 Biotest was forced to compensate a
13 year old boy for infecting him with HIV, and its licence was
revoked for selling contaminated products which had never been
screened for infectious disease.

This
licence has since been reinstated.118
In January 2013 Biotest launched a new liquid IVIG product called
Bivigam,119
but there was a recall of this new intravenous preparation at the
start of April because one batch inspected contained visible
particles which if injected could trigger stroke or heart attack.120

The
planned sale of PRUK is largely a result of the
2010 Government Spending Review which aimed to identify all public
sector assets that could be privatised. The sale of PRUK is expected
to raise a significant amount of revenue (estimates vary from
£100-£300 million, with the most recent at “over £200 million”
from the FT on 21 April 2013121)
and the Department of Health say private investment is required to
enable the growth and development of PRUK so it can better compete
internationally. DH officials said
that when the government purchased the US plasma supply company in
2002 there was an assumption that vCJD would spread throughout
Europe, creating a global shortage of plasma. This threat never
materialised and the majority of mainland European countries still
use their own population for plasma. As a result, the DH is
officially unconcerned about UK plasma product supply.

None
of the DH spokespeople that our researchers spoke to seemed to
understand the purpose or the importance of the company for the
safety of patients, and none seemed aware of the gamble involved in
buying these products on the open market given the track record of
repeated infections caused by profit-led economising on safety
procedures. Instead, bizarrely, our health officials seemed to focus
entirely on the profit potential of the company and not on its
essential function for our health.

They
also stressed that BPL only currently provides around 30% of the UK’s
plasma products, so the majority already come from the open market,
in which BPL itself competes. These statements show that we are
already being exposed to unnecessary risks by misguided pro-market
policy, an error about to be greatly compounded by disposing of our
means to achieve a safe national plasma supply.

The
DH told us that safeguards are provided by the regulated safety and
quality standards in the plasma product market. However there is
copious evidence from the infections that continue to occur in users
of open-market sourced plasma products that these are insufficient,
such as the 2008 Baxter heparin scandal that killed 81 patients122,
or the 2007 Hepatitis C infections traced to illegal plasma
collection in China123.

The
DH and our government mentioned only vCJD in relation to the sale of
PR UK and none of the many other infection risks. This represents an
astonishing lack of grasp of the health risks associated with plasma
products, given that new blood-borne diseases emerge every few years
globally, through changes in existing diseases or human infection
with animal diseases.

Blood, the market, and trade law

While the social
incentives to organise a safe and protected supply are plain, use of
a market to distribute blood products has from the 1950s been linked
with restraint of trade principles being invoked to force acceptance
of blood products known to be unsafe.

In 1955, unqualified
husband and wife entrepreneurs, Francis and Margaret Bass, spotted a
new business opportunity. They started to purchase and supply blood
to hospitals in Kansas.124
Their lack of medical training and exclusive focus on keeping costs
low and sales high resulted in inappropriate donor selection and
processing, aggressive marketing, and attempts to foist substandard
blood on to junior hospital staff. They once sent a consignment of
three bottles of blood to a hospital: two were visibly clotted (thus
unusable) and the third returned a positive test for syphilis. The
doctor in charge was threatened when he rejected them.

Local doctors were
horrified by the prospect of having to accept blood collected by the
Basses and together they formed a non-profit community blood bank to
provide their patients with safe supplies from screened volunteer
donors. The Basses reacted to this as a threat to their livelihood.

They hired a
telemarketer to sell blood insurance plans: a former barman whom they
also allowed to screen blood sellers and draw their blood. They
complained to the Kansas City Better Business Bureau, via the county
medical society accused the doctors of “most severe, unfair and
unwarranted persecution” due to their “special interests”, and
commenced a campaign of legal harassment.

An investigator
arrived from the Federal Trade Commission to investigate the Basses’
complaint. The doctors were tried before the Commission, accused of
violating the Federal Trade Commission Act “by mounting a
commercial boycott against the Basses to put them out of business”.
The verdict:

“the Community Blood Bank of Kansas City should cease and desist
from boycotting the Basses”

This decision was
upheld on appeal. The penalty for non-compliance was $5000 a day
($42,836 has the same purchasing power today as $5000 in 1956125).

Finally in 1969,
after a fourteen year battle, the Federal Court of Appeal ruled that
the Federal Trade Commission had exceeded its remit in bringing a
trade law action against a non-profit blood bank. Trade law applies
only to commodities provided through markets.

We have seen what
“exclusive focus on keeping costs low” did to patients at
Stafford Hospital under the control of the man who now heads the
NHS.126
The UK government is now intent on dragging all of our healthcare
into the trade and competition law net127
that reproduces the US trade laws that the Basses used to force their
bad blood into patients’ veins.

Actions to defend our health

Concern
now focuses on how UK patients can be confident of a safe and secure
supply of plasma for plasma products in the future, if the government
sells off the national asset acquired to provide and protect that
security.

In
early February, Lord Philip Hunt asked the government how they will
ensure a secure supply of plasma products for the NHS after selling
PRUK. Health Minister Earl Howe responded,

“Security
of supply of products to patients is of paramount importance to this
Government and is one of the key objectives integral to all the
options being considered as part of the sale process. [PR
UK subunit]
Bio Products Laboratory Ltd's supply to National Health Service
trusts will continue to be governed by existing supply agreements,
and the department will continue to ensure that effective legal and
commercial structures are in place to ensure that ongoing security of
supply from all suppliers is maintained.”128

Lord
Hunt was not reassured by this ministerial response, which invites us
to place our trust in fixed term contracts with a commercial supplier
which has already shown itself lacking in terms of both quality and
ethical conduct:

“I
don’t see how in reality the government can guarantee supplies
after a sale. When I was a minister we were anxious to secure the
future of these supplies for patients because they are critically
important. I’m not convinced that the government have got a hold of
this issue. What happens if the company that we sell to later runs
into financial problems? Contracts can be unreliable. There are so
many uncertainties that come with pursuing this plan which make it
incredibly risky.”

Biotest
will be trying to increase demand for its scarce products and there
will be no way for us to control this demand inflation so as to
protect an adequate quantity of supply to us at adequate quality.
Indeed the company already has a tie-up on albumin with China.129
In 2011, 180 tonnes of human albumin were sold in China, more than
40% of which were imported. Biotest has already doubled its output of
albumin to 40 tonnes annually130.
If we are to rely on Biotest for albumin, their strategy to
concentrate on Chinese growth might make it hard to deliver to us
should we have, for example, a serious fire with many people burned,
an increasingly likely occurrence given the closure of many fire
stations around the country.

Biotest
was the first pharmaceutical company to stop selling medicines to
Greece in its present economic crisis when ven Price Waterhouse said
that there was a moral duty to do so. In combination with this
company’s safety record, this lack of concern for patient welfare
highlights clearly that we should not seek to rely on this company
for secure access to safe supplies131.

The Archer report
termed UK infections of haemophiliacs by infected clotting factors a
"horrific human tragedy" but did not name any specific
medical workers or pharmaceutical companies as being responsible for
the deaths of around 2,000 hemophiliacs since the 1970s and for
infecting roughly 5,700 haemophiliacs with HIV, Hepatitis C or both:

"It
is difficult to avoid the conclusion that commercial interests took
precedence over public health concerns," said Archer, who
conducted an independent inquiry with the help of legal and medical
professionals.”132

MPs
have laid an Early Day Motion133
calling on the government to “cancel immediately the instruction to
sell PRUK and guarantee that this company will instead be held in
perpetuity to protect the health of the people of the UK”.
Labour MP Grahame Morris, member of the Health Select Committee,
commented,

"This
is another step too far in the privatisation of the NHS."

Geoff
Dunbar, a retired Methodist minister, has started a 38 Degrees
petition134
calling on Health Minister Dr Dan Poulter to “save our blood plasma
service” by scrapping the plan to sell off PRUK.

Ernst
and Young reportedly advised the government upon the sale in an
independent strategic review of PRUK for the Department of Health,
but this review is not in the public domain. The commercial
sensitivity of the sale restricts information being made available
and leaves parliament and the public with insufficient information to
scrutinise the rationale for the sale and its potential implications
for public health. An informed public debate about the safety and
wisdom of this sale is urgently required.

Conclusion

The Coalition is in
the process of selling an asset vital for national welfare without
making any arrangements to replace it. The privatisation of PR UK is
wholly against the UK’s national interest given the market
shortages of plasma and the fact that we cannot collect plasma in
this country because of the impact of the BSE disaster caused by Mrs
Thatcher’s ‘liberalisation’ policies. Another crop of
privatising politicians are exposing us to the problems that
inevitably hit countries which buy plasma products on the open
market, in which competition on price leads to pressure on producers
to reduce all costs including those of adequate infection control.

Rather than turning
sourcing of plasma products over to the open market, we should expand
the operations of PR UK, because buying plasma products on the open
market involves exposing patients to substantial risks. The market
creates perverse incentives to minimise safety procedures, and almost
every open market plasma producer has been caught at one time or
another in an infection or faulty product scandal. Should infections
result from inadequate safety procedures, plasma products
manufacturers can just shut down, allowing their owners to evade the
legal consequences of their cost-cutting. This arrangement puts all
the risks on patients, including for example asthmatic children and
cancer patients treated with IVIG.

When we know of such
problems, it cannot be responsible to choose to expose British
patients to these risks when an alternative is available.

That alternative
could be procured with ease now, but it will be hard to achieve
thereafter. There are few independent plasma harvesters left: as
demand is so high, the big companies are doing all they can to
sequester this precious resource in the few countries that allow its
purchase. Most other countries strive for self-sufficiency in plasma
supply. With a wholly government controlled plasma source we can
ensure that only the safest donors contribute to our supply and we
are in a position to ensure that the process is as safe as possible
at every stage. We are about to throw that security away and expose
ourselves to whatever product is put on the open market.

Historically,
social costs have attached to failure to take adequate safety
precautions in plasma processing:135
deaths, increased treatment costs, permanent disability, orphaning,
lawsuits brought by infected recipients, to public unrest over
exploitative plasma collection.136
Billions of dollars have been paid in compensation to victims and
their families around the world.

Former Secretary of
State for Health and medical doctor Lord Owen recommends:

“We in this country should do everything in our power to avoid
being reliant on open market tendering procedures where we can never
have absolute confidence in the source of the plasma, let alone the
strength of the regulations and quality of the inspectorates in the
countries from which we purchase. Plasma Resources UK Ltd is an
excellent insurance policy for the NHS, the Labour government was
wise to make this purchase, and you would be foolish to sell it off.
“

PRUK’s activities
should be reorientated away from profit-making back to public
service, and its supply developed to ensure our 100% ability to meet
the UK’s medical need for safe plasma products without recourse to
dangerous markets which reward corner-cutting on safety.

For our safety’s
sake, David Cameron should heed Lord Owen’s advice and cancel this
sale.

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IVIG is derived
from human plasma. The risk of transmission of infectious agents,
including viruses and, theoretically, the Creutzfeldt-Jakob disease
(CJD) agent, cannot be completely eliminated.

Hansard: Plasma Supplies (excerpts)

Lord Hunt of Kings Heath: On the evening of Monday
16 December, the Department of Health completed its purchase of the
largest remaining independent US plasma collector, Life Resources
Incorporated. This will secure long-term supplies of non-UK blood
plasma for the benefit of NHS patients, and ensure that the current
global plasma shortage will not reduce the availability to National
Health Service patients of life-saving plasma products.

Without continuing, secure supplies of US plasma, BPL faced
shutdown by 2004 with a consequent removal of massive volumes of
plasma products from the NHS market. Independent market analysis by
KPMG demonstrated that commercial suppliers would not be able to
provide sufficient, secure supplies of plasma products to the NHS if
BPL closed. Immediate action was therefore needed to secure long-term
supplies of high quality, US plasma for BPL.

Life Resources has supplied BPL with plasma since 1999. It has
extremely high quality and safety standards overseen by the US Food
and Drugs Administration and the UK Medicines Control Agency. All the
company's collection centres are inspected by BPL on a rolling
two-year programme. BPL's team also inspected every centre prior to
the purchase.

An effective corporate governance regime has been established for
the ongoing management of Life Resources. The company will be run by
its existing US management team and report to a US parent company,
DCI Biologicals Incorporated. DCI Biologicals will report to a UK
parent company, Plasma Resources Ltd. The board of Plasma Resources
Ltd is chaired by Richard Douglas, the Department of Health's
director of finance and investment.

Footnotes

1
Review of the Australian blood banking and plasma product sector.
March 2001 Government of Australia

13
Titmuss RM. The Gift Relationship: from human blood to social
policy.1972Vintage Books, New York

14
Janssen MCW, Mendys E. The Price of a
Price: On the Crowding Out of Social Norms. June 2001. Tinbergen
Institute.

15
Blood Plasma Safety: Plasma Product Risks and Manufacturers’
Compliance, Testimony before the Subcommittee on Human Resources,
Committee on Government Reform and Oversight, House of
Representatives, by Director of Health Services Quality and Public
Health Issues, Health Education and Human Services Division, 9
September 1998

43
Blood Plasma Safety: Plasma Product Risks and Manufacturers’
Compliance, Testimony before the Subcommittee on Human Resources,
Committee on Government Reform and Oversight, House of
Representatives, by Director of Health Services Quality and Public
Health Issues, Health Education and Human Services Division, 9
September 1998

136
The 1978 revolution in Nicaragua has
been partly attributed to plasma harvesting. Starr D. Blood: An epic
history of medicine and commerce. New York, Warner Books, 1998.
Canadian and French administrations have also been threatened by
blood scandals.

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